The roller pump will pause in response to a pressure alarm condition, as designed, but then may not resume operation as expected after the alarm condition has been cleared.

FDA DeterminedCause 2

DESIGN: Software Design

Action

Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.